Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout

NCT05818085 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ABP-671-301
• Study Type: interventional
• Target: 300
• Locations: 5 countries
• Sites: 57

Brief Summary

This is a multicenter, randomized, double-blind, Phase 2b/3 study to evaluate the efficacy and safety of ABP-671. Part 1 of the study will compare the efficacy and safety of different doses and regimens of ABP-671 with placebo and allopurinol. Part 2 of the study will compare the dosing regimen(s) of ABP-671 selected from Part 1 with placebo in participants who have not been enrolled for Part 1.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L)

  Week 28

Secondary Outcomes (2)

• Incidence of treatment-emergent adverse events (Safety and Tolerability)

  Week 28

• Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)

  Week 28

Study Arms (3)

ABP-671

EXPERIMENTAL

Drug: ABP-671

Allopurinol

ACTIVE COMPARATOR

Drug: Allopurinol

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Allopurinol DRUG

Standard of care according to American College of Rheumatology (ACR) guideline for the management of gout

Allopurinol

Placebo OTHER

ABP-671 matching placebo

Placebo

ABP-671 DRUG

Low, medium or high dose (Part 1); Selected dose(s) (Part 2)

ABP-671

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants aged ≥19 and \<70 years of age at the time of informed consent.
• A body mass index (BMI) of ≥18 kg/m2 to ≤40 kg/m2.
• Diagnosis of gout per American College of Rheumatology/European Alliance of Associations for Rheumatology 2015 Gout Classification Criteria and must meet the criteria as follows:
• At Screening, participants with gout on ULT (including allopurinol) must be willing to discontinue ULT.
• At Screening, participants with gout who are not currently treated with any UA lowering therapy must have an sUA ≥7.5 mg/dL (≥0.450 mmol/L).
• At the confirmatory sUA visit, all participants must have an sUA ≥7.0 mg/dL (≥0.420 mmol/L).
• Women of childbearing potential (WOCBP) must be surgically sterile (eg, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or willing to use acceptable and highly effective double contraception from Screening until at least 30 days after the last dose of the study drug. Double contraception is defined as a condom AND one other form of the following:
• Established hormonal contraception (with approved oral contraceptive pills, long-acting implantable hormones, injectable hormones);
• A vaginal ring or an intrauterine device OR
• Documented evidence of surgical sterilization at least 6 months prior to Screening (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men \[with appropriate post-vasectomy documentation of the absence of sperm in semen\] provided the male partner is the sole partner). The absence of records will not exclude screening the participant; if medical records cannot be obtained, serum pregnancy testing will be conducted to confirm the participant is not pregnant.
• Note: Women not of childbearing potential must be postmenopausal for ≥12 months. Postmenopausal status will be confirmed through follicle stimulating hormone (FSH) concentration testing.
• Men must be surgically sterile (\>30 days since vasectomy), abstinent, or if engaged in sexual relations with a female partner of childbearing potential, the participant must use an acceptable form of contraception from Screening until at least 30 days after the last dose of the study drug. Acceptable methods of contraception include the use of condoms in addition to the use of an effective contraceptive for the female partner that includes approved oral contraceptive pills, long-acting implantable hormones, injectable hormones, a vaginal ring, or an intrauterine device. Participants who practice abstinence (abstinence from penile-vaginal intercourse) are eligible when this is in line with their preferred and usual lifestyle. In addition, men must not donate sperm for at least 30 days after the last dose of the study drug.

You may not qualify if:

• History of rheumatoid arthritis or other autoimmune disease.
• Clinically significant hepatic, cardiovascular, renal, neoplastic, psychiatric, or hematological disorders such as polycythemia vera, sickle cell disease, or myelodysplastic disorder.
• Positive test result for HIV, hepatitis B surface antigen, or hepatitis C virus antibody. Active hepatitis C virus infection is defined as a participant with a positive hepatitis C antibody and detectable hepatitis C viral load RNA.
• Participants who, in the opinion of the Investigator, have a high genetic risk of allopurinol hypersensitivity syndrome unless they have been found to be negative for Human leukocyte antigen (HLA)-B\*5801, either clinically by prior exposure to allopurinol or by laboratory evaluation.
• Liver function tests \>2x the laboratory upper limit of normal (ULN) range of aspartate aminotransferase, alkaline phosphatase, or alanine aminotransferase; total bilirubin \>1.5x ULN at Screening.
• Inadequate renal function with serum creatinine \>1.5 mg/dL (\>0.133 mmol/L) or estimated glomerular filtration rate (eGFR) \< 60 mL/min/m2 (by the 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine-based eGFR equation).
• History of malignancy within the previous 5 years; with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia, or treated in situ grade 1 cervical cancer.
• History within the last 12 months of unstable angina, New York Heart Association functional class III or IV heart failure, myocardial infarction, stroke, venous thromboembolism, or a history of percutaneous coronary intervention.
• Uncontrolled hypertension (systolic BP ≥160 mmHg and/or diastolic BP ≥90 mmHg). If BP is controlled while taking antihypertensive medication, the participant must be on stable dose for previous 2 months.
• Active liver disease or impaired hepatic function as assessed by liver function tests.
• Received any investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening.
• Any other medical or psychological condition, that, in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the participant, interfere with the participant's ability to comply with the protocol requirements to complete the study, or potentially compromise the results or interpretation of the study.
• Pregnant, breastfeeding, or planning a pregnancy during the study or ≤30 days after the last dose of the study drug.
• Intolerant or unwilling to take colchicine or naproxen.

Sponsors & Collaborators

• Atom Therapeutics Co., Ltd: lead

Study Sites (57)

Alliance for Multispecialty Research

Tempe, Arizona, 85281, United States

Location

Tucson Neuroscience Research, LLC

Tuscon, Arizona, 85710, United States

Location

Anaheim Clinical Trials (Cenexel ACT)

Anaheim, California, 92801, United States

Location

Center for Clinical Trials of Sacramento

Sacramento, California, 95823, United States

Location

Access Research Institute

Brooksville, Florida, 34613, United States

Location

Nature Coast Clinical Reasearch

Crystal River, Florida, 34429, United States

Location

JY Research Institute Inc.

Cutler Bay, Florida, 33189, United States

Location

Accel Clinical Research Site

DeLand, Florida, 32720, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Accel Research Sites Network - St. Pete-Largo Clinical Research Unit

Largo, Florida, 33777, United States

Location

A & D Doctor Center

Miami, Florida, 33135, United States

Location

Bioclinical Research Alliance

Miami, Florida, 33155, United States

Location

Cordova Research Institute

Miami, Florida, 33155, United States

Location

Century Research LLC

Miami, Florida, 33173, United States

Location

ITB Research

Miami, Florida, 33173, United States

Location

Combined Research Orlando Phase I-IV

Orlando, Florida, 32807, United States

Location

New Horizons Research

Palmetto Bay, Florida, 33158, United States

Location

Advanced Clinical Research of Atlanta

Atlanta, Georgia, 30309, United States

Location

Centricity Research

Columbus, Georgia, 31904, United States

Location

Alliance for Multispecialty Research, LLC.

Newton, Kansas, 67114, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

AMR

New Orleans, Louisiana, 70119, United States

Location

Annapolis Internal Medicine/CCT Research

Annapolis, Maryland, 21401, United States

Location

DelRicht Research of Gulfport

Gulfport, Mississippi, 39501, United States

Location

Quality Clinical Research, Inc

Omaha, Nebraska, 68114, United States

Location

Santa Rosa Medical Center

Las Vegas, Nevada, 89119, United States

Location

Inspire Santa Fe Medical Group

Santa Fe, New Mexico, 87505, United States

Location

OnSite Clinical Solutions

Salisbury, North Carolina, 28144, United States

Location

DelRicht Research

Tulsa, Oklahoma, 74133, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

ClinSearch

Chattanooga, Tennessee, 37421, United States

Location

Medical Care/CCT

Elizabethton, Tennessee, 37643, United States

Location

PanAmerican Clinical Research, LLC

Brownsville, Texas, 78520, United States

Location

Quality Research Inc.

San Antonio, Texas, 78209, United States

Location

Centricity Research

Suffolk, Virginia, 23435, United States

Location

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, 2148, Australia

Location

Emeritus Research Sydney

Botany, New South Wales, 2019, Australia

Location

Paratus Clinical Research Central Coast

Kanwal, New South Wales, 2259, Australia

Location

A R Houston Medical Pty Ltd

Kippa-Ring, Queensland, 4021, Australia

Location

Emeritus Research Melbourne

Camberwell, Victoria, 3124, Australia

Location

Austin Health - Repatriation Hospital

Heidelberg, Victoria, 3084, Australia

Location

New Hospitals

Tbilisi, 0114, Georgia

Location

Evex Hospitals Caraps Medline

Tbilisi, 0159, Georgia

Location

Aversi Clini

Tbilisi, 0160, Georgia

Location

The First Medical Center

Tbilisi, 0180, Georgia

Location

Academician Vakhtang Bochorishvili Clinic

Tbilisi, 0186, Georgia

Location

Innova

Tbilisi, 0186, Georgia

Location

Clinical Research Center (CRC)

Guatemala City, 01010, Guatemala

Location

Clínica Médica Especializada en Medicina Interna y Reumatología (CREER)

Guatemala City, 01010, Guatemala

Location

Clínica Médica Especializada en Medicina Interna y Reumatología

Guatemala City, 01010, Guatemala

Location

Clínica Médica Especializada en Medicina Interna

Guatemala City, 01010, Guatemala

Location

Clínica Médica Especializada en Medicina Interna y Reumatología

Guatemala City, 1011, Guatemala

Location

Buddhist Dalin Tzu Chi General Hospital

Chiayi City, 62247, Taiwan

Location

Chang Gung Memorial Hospital CGMH

Kaohsiung City, 833, Taiwan

Location

Chung Shan Medical Univ. Hospital

Taichung, 402367, Taiwan

Location

Cheng-Shin General Hospital

Taipei, 112401, Taiwan

Location

Chang Gung Memorial Hospital LinKou

Taoyuan District, 333423, Taiwan

Location

MeSH Terms

Conditions

Gout

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: August 11, 2023
• Primary Completion: January 30, 2025
• Study Completion: March 30, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5); GU (5); US (35); GE (6); AU (6)